Integrated sliding seal fluid pathway connection and drug containers for drug delivery pumps

ABSTRACT

A fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/756,638, filed on Jan. 25, 2013, which is included by referenceherein in its entirety for all purposes.

FIELD

This invention relates to drug delivery pumps. More particularly, thisinvention relates to fluid pathway connections which are integrated intoor within drug containers, drug delivery pumps which utilize theseconnections, the methods of operating such devices, and the methods ofassembling such devices.

BACKGROUND

Parenteral delivery of various drugs, i.e., delivery by means other thanthrough the digestive track, has become a desired method of drugdelivery for a number of reasons. This form of drug delivery byinjection may enhance the effect of the substance being delivered andensure that the unaltered medicine reaches its intended site at asignificant concentration. Similarly, undesired side effects associatedwith other routes of delivery, such as systemic toxicity, canpotentially be avoided through parenteral delivery. By bypassing thedigestive system of a mammalian patient, one can avoid degradation ofthe active ingredients caused by the catalytic enzymes in the digestivetract and liver and ensure that a necessary amount of drug, at a desiredconcentration, reaches the targeted site.

Traditionally, manually operated syringes and injection pens have beenemployed for delivering parenteral drugs to a patient. More recently,parenteral delivery of liquid medicines into the body has beenaccomplished by administering bolus injections using a needle andreservoir, continuously by gravity driven dispensers, or via transdermalpatch technologies. Bolus injections often imperfectly match theclinical needs of the patient, and usually require larger individualdoses than are desired at the specific time they are given. Continuousdelivery of medicine through gravity-feed systems compromises thepatient's mobility and lifestyle, and limits the therapy to simplisticflow rates and profiles. Another form of drug delivery, transdermalpatches, similarly has its restrictions. Transdermal patches oftenrequire specific molecular drug structures for efficacy, and the controlof the drug administration through a transdermal patch is severelylimited.

Ambulatory infusion pumps have been developed for delivering liquidmedicaments to a patient. These infusion devices have the ability tooffer sophisticated fluid delivery profiles accomplishing bolusrequirements, continuous infusion and variable flow rate delivery. Theseinfusion capabilities usually result in better efficacy of the drug andtherapy and less toxicity to the patient's system. Currently availableambulatory infusion devices are expensive, difficult to program andprepare for infusion, and tend to be bulky, heavy and very fragile.Filling these devices can be difficult and require the patient to carryboth the intended medication as well as filling accessories. The devicesoften require specialized care, maintenance, and cleaning to assureproper functionality and safety for their intended long-term use, andare not cost-effective for patients or healthcare providers.

As compared to syringes and injection pens, pump type delivery devicescan be significantly more convenient to a patient, in that doses of thedrug may be calculated and delivered automatically to a patient at anytime during the day or night. Furthermore, when used in conjunction withmetabolic sensors or monitors, pumps may be automatically controlled toprovide appropriate doses of a fluidic medium at appropriate times ofneed, based on sensed or monitored metabolic levels. As a result, pumptype delivery devices have become an important aspect of modern medicaltreatments of various types of medical conditions, such as diabetes, andthe like.

While pump type delivery systems have been utilized to solve a number ofpatient needs, manually operated syringes and injection pens oftenremain a preferred choice for drug delivery as they now provideintegrated safety features and can easily be read to identify the statusof drug delivery and the end of dose dispensing. However, manuallyoperated syringes and injections pens are not universally applicable andare not preferred for delivery of all drugs. There remains a need for anadjustable (and/or programmable) infusion system that is precise andreliable and can offer clinicians and patients a small, low cost, lightweight, simple to use alternative for parenteral delivery of liquidmedicines.

SUMMARY

The present invention provides container connections which maintain thesterility of the fluid pathway and which are integrated into the drugcontainer, and drug delivery pumps which incorporate such sterile fluidpathway connections to drug containers, the methods of operating suchdevices, and the methods of assembling such devices. The fluid pathwayconnections of the present invention provide integrated safety featureswhich ensure the sterility of the fluid pathway before, during, andafter drug delivery. In one aspect, the fluid pathway remainsdisconnected from the drug container until the device has been initiatedby the user. In a second aspect, the fluid pathway maintains thesterility of the piercing member prior to connection with the drugcontainer within a sterile cavity prior to activation by the user. Uponactivation by the user, the sliding pierceable seal is translated, suchas by pneumatic pressure or force within the drug fluid, towards asubstantially fixed piercing member such that the sliding pierceableseal is pierced and the fluid pathway is connected or opened to enablefluid flow through the fluid pathway for drug delivery into the body ofthe user. Accordingly, the novel devices of the present inventionalleviate one or more of the problems associated with prior art devices,such as those referred to above.

A drug pump, such as an infusion pump or a bolus injector, may be neededto deliver a particular amount of drug fluid within a period of time.When delivering fluid subcutaneously it is important to control the flowof fluid that is delivered into the patient and to maintain thesterility of the drug container and fluid pathway prior to activation oroperation of the drug delivery device. It may be desired that the fluidpathway connection remains disconnected, for container integrity,sterility, and other purposes, until the user has activated the deviceand initiated drug flow from a drug container to the patient. Some drugpump systems may utilize one or more active fluid pathway controlmechanisms to prevent premature fluid pathway connection and/or drugdelivery. Other drug pump systems are configured such that fluid pathwayconnection is made upon manufacture, and drug delivery is blocked untildesired by the user. Such designs do not provide the beneficialadvantages associated with maintaining container integrity and sterilityof the internal components of the drug delivery device. The presentinvention provides an integrated fluid pathway connection mechanism fordrug delivery pumps. The novel embodiments of the present invention atonce provide a connection mechanism to open or connect a sterile fluidpathway between a drug container and a fluid conduit without addingunnecessary steps of use for the user. This is enabled by utilizingactivation of the drive mechanism and translation of the plunger seal,and the resulting pneumatic pressure within the drug fluid, to forcetranslation of a sliding pierceable seal. The translation of the slidingpierceable seal causes it to impact upon an initially substantiallystationary or fixed piercing member to open a fluid pathway between thedrug container and the fluid conduit.

Accordingly, the embodiments of the present invention provide a sterilefluid pathway connection that is integrated into a drug container andopened, connected, activated, or otherwise enabled by the operation ofthe device and drive mechanism. The activation of the drive mechanismand the force transferred from the drive mechanism to the plunger sealis, itself, used to open a sterile fluid pathway between the drugcontainer and the fluid conduit. Accordingly, container integrity andsterility of the drug container may be maintained prior to and duringoperation of the device. This novel configuration also automates thesterile fluid pathway connection step, greatly reducing the complexityof the device and operational steps needed to be performed by the deviceor the user. The novel embodiments of the present invention also permitmore device component configurations and reduce the layout or overallfootprint of the device, since no separate sterile fluid pathwayconnection mechanism are needed on the cap side of the drug container.The present invention may also be fully implemented or utilized instandard drug fill-finish processes, including processes that requirethe pulling of a vacuum. Additionally, the present invention may alsointegrate a number of different status indication mechanisms into thedevice, including utilizing the piercing member and the plunger seal asparts of an end-of-dose indication mechanism. Such components anddevices provide true end-of-dose indication coupled to the actual traveland drug delivery status of the plunger seal.

In a first embodiment, the present invention provides a fluid pathwayconnection which includes a piercing member, a connection hub, and asliding pierceable seal. The piercing member is initially retained in afirst position within a sterile cavity between the connection hub andthe sliding pierceable seal. Upon activation by the user, the pierceableseal is caused to move to a second position where the pierceable seal ispenetrated by the piercing member. Force, such as pneumatic force,applied on the sliding pierceable seal on the side opposing the sterilecavity causes translation of the sliding pierceable seal towards thepiercing member. The translation of the sliding pierceable seal causesit to impact upon an initially substantially stationary or fixedpiercing member to open a fluid pathway through the sliding piercingmember. Accordingly, the sliding pierceable seal is configured to movefrom the first position to the second position by a force applied by adrug fluid on the sliding pierceable seal. Penetration by the piercingmember of the sliding pierceable seal upon movement of the slidingpierceable seal from the first position to the second position opens afluid pathway through the sliding piercing member and the piercingmember to a fluid conduit.

In at least one embodiment, the pierceable seal has a seal barrier thatmay be penetrated by the piercing member. The piercing member mayinitially be in contact with, or adjacent to, the seal barrier. Thefluid pathway connection may further include a seal mount attached tothe sliding pierceable seal, wherein the seal mount is capable ofengaging with and translating upon the connection hub and wherein thepiercing member is initially in contact with, or adjacent to, the sealbarrier. The piercing member may be configured to pass into theconnection hub and connect to a fluid conduit. In another embodiment,the connection hub may connect the piercing member to the fluid conduit,and the fluid conduit may be at least partially a part of the connectionhub.

The fluid pathway connections of the present invention may furtherinclude one or more interconnects and, optionally, one or morecorresponding contacts to transmit a signal to the user. For example,the interconnect may be within or at least partially proximal to aplunger seal translatable within a drug container such that the piercingmember is capable of penetrating the plunger seal and acting as acontact for the interconnect to transmit a signal to the user.Additionally or alternatively, one of either the interconnects and/orthe contacts is within or at least partially proximal to a plunger sealtranslatable within a drug container and the other is within or at leastpartially distal to the sliding pierceable seal to transmit a signal tothe user when the plunger seal and the sliding pierceable seal aresubstantially in contact. A number of known interconnects and contactsmay be utilized within the embodiments of the present invention, whichwould readily be appreciated by an ordinarily skilled artisan. Forexample, a range of: Hall effect sensors; giant magneto resistance (GMR)or magnetic field sensors; optical sensors; capacitive or capacitancechange sensors; ultrasonic sensors; and linear travel, LVDT, linearresistive, or radiometric linear resistive sensors; and combinationsthereof, which are capable of coordinating to transmit a signal to theuser may be utilized for such purposes. Additionally, the fluid pathwayconnections may include one or more flow restrictors. In at least oneembodiment, the connection hub may at least partially function as afluid conduit and/or flow restrictor. In at least one embodiment, thefluid pathway connection further includes a filter. A number of knownfilters may be utilized within the embodiments of the present invention,which would readily be appreciated by an ordinarily skilled artisan. Forexample the filter may be a permeable membrane, semi-permeable membrane,and/or porous membrane, which encloses the sterile cavity from theoutside environment.

In another embodiment, the present invention provides an integratedfluid pathway connection and drug container having a piercing member, aconnection hub, and a sliding pierceable seal integrated at leastpartially within a drug container having a barrel and a plunger seal.The sliding pierceable seal is translatable upon a connection post ofthe connection hub and is configured to move from a first position,where the piercing member is initially retained within a sterile cavitybetween the connection hub and the sliding pierceable seal, to a secondposition, where the pierceable seal has been penetrated by the piercingmember. The drug container contains a drug chamber between the slidingpierceable seal and the plunger seal to initially retain a drug fluid,and wherein the sliding pierceable seal is configured to move from thefirst position to the second position by a force applied by the drugfluid on the sliding pierceable seal. In at least one embodiment, thepierceable seal has a seal barrier that may be penetrated by thepiercing member and the piercing member is initially in contact with, oradjacent to, the seal barrier.

The integrated fluid pathway connection may further include a seal mountattached to the sliding pierceable seal, wherein the seal mount slidablyengages the connection hub to permit translation of the slidingpierceable seal in the distal direction but prevent translation in theproximal direction. Such a configuration may be utilized to permit thedrug chamber of the drug container to be evacuated, such as by vacuum,prior to filling with a drug fluid without compromising the function ofthe sterile fluid pathway connection. In at least one embodiment, theconnection hub has a header with a conduit port, a chamber, and a vacuumport with a channel that leads into the chamber such that the sterilecavity may be evacuated through the channel. The conduit port and mayhave a membrane or seal to permit fluid flow out of the chamber.Similarly, the vacuum port may be capable of being plugged, such as by apolymeric plug. Such configurations may allow, for example, the sterilecavity to be evacuated to maintain sterility, the maintenance of apressure equilibrium between the sterile cavity and the opposing side ofthe sliding pierceable seal, and/or assist in maintaining the relativepositions of the components prior to operation of the device by theuser.

In at least one embodiment of the present invention, the slidingpierceable seal is translatable upon the connection post of theconnection hub and is further configured to move from the secondposition, where the pierceable seal has been penetrated by the piercingmember, to a third position where one or more interconnects and one ormore corresponding contacts are permitted to transmit a signal to theuser. In one such embodiment, one of either the interconnects and thecontacts is upon an aspect of a drive mechanism and the other is withinor at least partially proximal to the plunger seal to transmit a signalto the user when the plunger seal and the sliding pierceable seal aresubstantially in contact. Alternatively, one of either the interconnectsand the contacts is within or at least partially distal to thepierceable sliding seal and the other is proximal to the connection hubto transmit a signal to the user when the plunger seal and the slidingpierceable seal are substantially in contact. A number of knowninterconnects and contacts may be utilized within the embodiments of thepresent invention, which would readily be appreciated by an ordinarilyskilled artisan. For example, a range of: Hall effect sensors; giantmagneto resistance (GMR) or magnetic field sensors; optical sensors;capacitive or capacitance change sensors; ultrasonic sensors; and lineartravel, LVDT, linear resistive, or radiometric linear resistive sensors;and combinations thereof, which are capable of coordinating to transmita signal to the user may be utilized for such purposes. Additionally,the fluid pathway connections may include one or more flow restrictors.In at least one embodiment, the connection hub may at least partiallyfunction as a fluid conduit and/or flow restrictor. In at least oneembodiment, the fluid pathway connection further includes a filter. Anumber of known filters may be utilized within the embodiments of thepresent invention, which would readily be appreciated by an ordinarilyskilled artisan. For example the filter may be a permeable membrane,semi-permeable membrane, and/or porous membrane, which encloses thesterile cavity from the outside environment.

In yet another embodiment, the present invention provides a drugdelivery pump with integrated sterility maintenance features comprises ahousing within which an activation mechanism, an insertion mechanism,and a drug container having a plunger seal may be mounted. The drugcontainer is connected at one end to a drive mechanism and at anotherend to a fluid pathway connection. The fluid pathway connection includesa piercing member, a connection hub, and a sliding pierceable seal,wherein the sliding pierceable seal is configured to move from a firstposition, where the piercing member is initially retained within asterile cavity between the connection hub and the sliding pierceableseal, to a second position, where the pierceable seal has beenpenetrated by the piercing member. The drug container contains a drugchamber between the sliding pierceable seal and the plunger seal toinitially retain a drug fluid, and wherein the sliding pierceable sealis configured to move from the first position to the second position bya force applied by the drug fluid on the sliding pierceable seal. In atleast one embodiment, the pierceable seal has a seal barrier that may bepenetrated by the piercing member and the piercing member is initiallyin contact with, or adjacent to, the seal barrier.

The drug pump may further include a seal mount attached to the slidingpierceable seal, wherein the seal mount slidably engages the connectionhub to permit translation of the sliding pierceable seal in the distaldirection but prevent translation in the proximal direction. Such aconfiguration may be utilized to permit the drug chamber of the drugcontainer to be evacuated, such as by vacuum, prior to filling with adrug fluid without compromising the function of the sterile fluidpathway connection. In at least one embodiment, the connection hub has aheader with a conduit port, a chamber, and a vacuum port with a channelthat leads into the chamber such that the sterile cavity may beevacuated through the channel. The conduit port and may have a membraneor seal to permit fluid flow out of the chamber. Similarly, the vacuumport may be capable of being plugged, such as by a polymeric plug. Suchconfigurations may allow, for example, the sterile cavity to beevacuated to maintain sterility, the maintenance of a pressureequilibrium between the sterile cavity and the opposing side of thesliding pierceable seal, and/or assist in maintaining the relativepositions of the components prior to operation of the device by theuser.

In at least one embodiment of the present invention, the slidingpierceable seal is translatable upon the connection post of theconnection hub and is further configured to move from the secondposition, where the pierceable seal has been penetrated by the piercingmember, to a third position where one or more interconnects and one ormore corresponding contacts are permitted to transmit a signal to theuser. The one or more interconnects and the one or more correspondingcontacts are configured such that either: (a.) one of either theinterconnects and the contacts is upon an aspect of the drive mechanismand the other is within or at least partially proximal to the plungerseal to transmit a signal to the user when the plunger seal and thesliding pierceable seal are substantially in contact; or (b.) one ofeither the interconnects and the contacts is within or at leastpartially distal to the pierceable sliding seal and the other isproximal to the connection hub to transmit a signal to the user when theplunger seal and the sliding pierceable seal are substantially incontact. A number of known interconnects and contacts may be utilizedwithin the embodiments of the present invention, which would readily beappreciated by an ordinarily skilled artisan. For example, a range of:Hall effect sensors; giant magneto resistance (GMR) or magnetic fieldsensors; optical sensors; capacitive or capacitance change sensors;ultrasonic sensors; and linear travel, LVDT, linear resistive, orradiometric linear resistive sensors; and combinations thereof, whichare capable of coordinating to transmit a signal to the user may beutilized for such purposes. Additionally, the fluid pathway connectionsmay include one or more flow restrictors. In at least one embodiment,the connection hub may at least partially function as a fluid conduitand/or flow restrictor. In at least one embodiment, the fluid pathwayconnection further includes a filter. A number of known filters may beutilized within the embodiments of the present invention, which wouldreadily be appreciated by an ordinarily skilled artisan. For example thefilter may be a permeable membrane, semi-permeable membrane, and/orporous membrane, which encloses the sterile cavity from the outsideenvironment.

The novel devices of the present invention provide container connectionswhich maintain the sterility of the fluid pathway and which areintegrated into the drug container, and drug delivery pumps whichincorporate such integrated sterile fluid pathway connections to drugcontainers. Because the fluid path is disconnected until drug deliveryis desired by the user, the sterility of the fluid pathway connection,the drug container, the drug fluid, and the device as a whole ismaintained. Furthermore, the novel configurations of the fluid pathwayconnections and drug pumps of the present invention maintain thesterility of the fluid path through operation of the device. Because thepath that the drug fluid travels within the device is entirelymaintained in a sterile condition, only these components need besterilized during the manufacturing process. Such components include thedrug container of the drive mechanism, the fluid pathway connection, thesterile fluid conduit, and the insertion mechanism. In at least oneembodiment of the present invention, the power and control system, theassembly platform, the control arm, the activation mechanism, thehousing, and other components of the drug pump do not need to besterilized. This greatly improves the manufacturability of the deviceand reduces associated assembly costs. Accordingly, the devices of thepresent invention do not require terminal sterilization upon completionof assembly. A further benefit of the present invention is that thecomponents described herein are designed to be modular such that, forexample, the fluid pathway connection and other components of the devicemay be integrated into a housing and readily interface to function as adrug pump.

In a further embodiment, the present invention provides a method ofassembly of an integrated sterile fluid pathway connection and drugcontainer. The sterile fluid pathway connection may first be assembledand then attached, mounted, connected, or otherwise integrated into drugcontainer such that at least a portion of the sliding pierceable seal iscontained within the drug container. The drug container may then befilled with a fluid for delivery to the user and plugged with a plungerseal at an end opposite the sliding pierceable seal. The barrel may befilled with a drug fluid through the open proximal end prior toinsertion of the plunger seal from the proximal end of the barrel. Adrive mechanism may then be attached to the proximal end of the drugcontainer such that a component of the drive mechanism is capable ofcontacting the plunger seal. An insertion mechanism may be assembled andattached to the other end of the fluid conduit. This entiresub-assembly, including drive mechanism, drug container, fluid pathwayconnection, fluid conduit, and insertion mechanism may be sterilized, asdescribed above, before assembly into a drug pump. Certain components ofthis sub-assembly may be mounted to an assembly platform within thehousing or directly to the interior of the housing, while othercomponents may be mounted to a guide, channel, or other component oraspect for activation by the user. A method of manufacturing a drug pumpincludes the step of attaching both the fluid pathway connection anddrug container, either separately or as a combined component, to anassembly platform or housing of the drug pump. The method ofmanufacturing further includes attachment of the drive mechanism, drugcontainer, and insertion mechanism to the assembly platform or housing.The additional components of the drug pump, as described herein,including the power and control system, the activation mechanism, andthe control arm may be attached, preformed, or pre-assembled to theassembly platform or housing. An adhesive patch and patch liner may beattached to the housing surface of the drug pump that contacts the userduring operation of the device.

A method of operating the drug pump includes one or more of thefollowing steps: activating, by a user, the activation mechanism;displacing a control arm to actuate an insertion mechanism; activating adrive control mechanism to push the plunger seal, connect the sterilefluid pathway connection, and drive fluid drug flow through the drugpump, wherein translating the fluid pathway connection causes a piercingmember to penetrate a sliding pierceable seal to thereby open a fluidpath from the drug container to the fluid conduit. The drive controlmechanism may be activated by actuating a power and control system. Themethod may further include the step of: engaging an optional on-bodysensor prior to activating the activation mechanism. Furthermore, themethod of operation may include translating a plunger seal within thedrive control mechanism and drug container to force fluid drug flowthrough the drug container, the fluid pathway connection, the fluidconduit, and the insertion mechanism for delivery of the fluid drug tothe body of a user.

The novel devices of the present invention provide container connectionswhich maintain the sterility of the fluid pathway and which areintegrated into the drug container, and drug delivery pumps whichincorporate such integrated sterile fluid pathway connections to drugcontainers. Such devices are safe and easy to use, and are aestheticallyand ergonomically appealing for self-administering patients. Throughoutthis specification, unless otherwise indicated, “comprise,” “comprises,”and “comprising,” or related terms such as “includes” or “consists of,”are used inclusively rather than exclusively, so that a stated integeror group of integers may include one or more other non-stated integersor groups of integers. As will be described further below, theembodiments of the present invention may include one or more additionalcomponents which may be considered standard components in the industryof medical devices. The components, and the embodiments containing suchcomponents, are within the contemplation of the present invention andare to be understood as falling within the breadth and scope of thepresent invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following non-limiting embodiments of the invention are describedherein with reference to the following drawings, wherein:

FIG. 1A shows an isometric view of a drug delivery pump having anintegrated sterile fluid pathway connection and drug container,according to one embodiment of the present invention;

FIG. 1B shows an isometric view of the interior components of the drugdelivery pump shown in FIG. 1A;

FIG. 1C shows an isometric view of the bottom of the drug delivery pumpshown in FIG. 1A;

FIG. 2A shows an isometric view of an integrated sterile fluid pathwayconnection and drug container, according to one embodiment of thepresent invention;

FIG. 2B shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 2A;

FIG. 3A shows an exploded view of an integrated sterile fluid pathwayconnection and drug container, exploded along a longitudinal axis “A,”according to at least one embodiment of the present invention;

FIG. 3B shows a cross-sectional exploded view of the integrated sterilefluid pathway connection and drug container shown in FIG. 3A;

FIG. 4A shows a cross-sectional view of an integrated sterile fluidpathway connection and drug container, as shown in FIG. 2A, prior touser activation;

FIG. 4B shows a cross-sectional view of an integrated sterile fluidpathway connection and drug container, as shown in FIG. 2A, with thefluid pathway connected;

FIG. 4C shows a cross-sectional view of an integrated sterile fluidpathway connection and drug container, as shown in FIG. 2A, at the endof drug delivery;

FIG. 5A shows an isometric view, from the proximal perspective, of theintegrated sterile fluid pathway connection according to one embodimentof the present invention;

FIG. 5B shows an exploded view, from the proximal perspective, of theintegrated sterile fluid pathway connection shown in FIG. 5A;

FIG. 5C shows an isometric view, from the proximal perspective, of theintegrated sterile fluid pathway connection, according to anotherembodiment of the present invention;

FIG. 5D shows a cross-sectional view of the integrated sterile fluidpathway connection shown in FIG. 5C;

FIG. 6A shows a cross-sectional view of an integrated sterile fluidpathway connection and drug container, according to another embodimentof the present invention, prior to user activation;

FIG. 6B shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 6A, with the fluidpathway connected;

FIG. 6C shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 6A, at the end ofdrug delivery;

FIG. 6D shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 6A, after additionalcompliance travel and/or end-of-dose indication;

FIG. 7A shows a cross-sectional view of an integrated sterile fluidpathway connection and drug container, according to yet anotherembodiment of the present invention, prior to user activation;

FIG. 7B shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 7A, with the fluidpathway connected;

FIG. 7C shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 7A, at the end ofdrug delivery;

FIG. 7D shows a cross-sectional view of the integrated sterile fluidpathway connection and drug container shown in FIG. 7A, after additionalcompliance travel and/or end-of-dose indication.

DETAILED DESCRIPTION

As used herein to describe the integrated sterile fluid pathwayconnection and drug containers, drug delivery pumps, or any of therelative positions of the components of the present invention, the terms“axial” or “axially” refer generally to a longitudinal axis “A” aroundwhich the drive mechanisms are preferably positioned, although notnecessarily symmetrically there-around. The term “radial” refersgenerally to a direction normal to axis A. The terms “proximal,” “rear,”“rearward,” “back,” or “backward” refer generally to an axial directionin the direction “P”. The terms “distal,” “front,” “frontward,”“depressed,” or “forward” refer generally to an axial direction in thedirection “D”. As used herein, the term “glass” should be understood toinclude other similarly non-reactive materials suitable for use in apharmaceutical grade application that would normally require glass,including but not limited to certain non-reactive polymers such ascyclic olefin copolymers (COC) and cyclic olefin polymers (COP). Theterm “plastic” may include both thermoplastic and thermosettingpolymers. Thermoplastic polymers can be re-softened to their originalcondition by heat; thermosetting polymers cannot. As used herein, theterm “plastic” refers primarily to moldable thermoplastic polymers suchas, for example, polyethylene and polypropylene, or an acrylic resin,that also typically contain other ingredients such as curatives,fillers, reinforcing agents, colorants, and/or plasticizers, etc., andthat can be formed or molded under heat and pressure. As used herein,the term “plastic” is not meant to include glass, non-reactive polymers,or elastomers that are approved for use in applications where they arein direct contact with therapeutic liquids that can interact withplastic or that can be degraded by substituents that could otherwiseenter the liquid from plastic. The term “elastomer,” “elastomeric” or“elastomeric material” refers primarily to cross-linked thermosettingrubbery polymers that are more easily deformable than plastics but thatare approved for use with pharmaceutical grade fluids and are notreadily susceptible to leaching or gas migration under ambienttemperature and pressure. “Fluid” refers primarily to liquids, but canalso include suspensions of solids dispersed in liquids, and gassesdissolved in or otherwise present together within liquids inside thefluid-containing portions of the pumps. According to various aspects andembodiments described herein, reference is made to a “biasing member”,which may be any member that is capable of storing and releasing energy.Non-limiting examples include a spring, such as for example a coiledspring, a compression or extension spring, a torsional spring, and aleaf spring, a resiliently compressible or elastic band, or any othermember with similar functions. In at least one embodiment of the presentinvention, the biasing member is a spring, preferably a compressionspring.

The novel devices of the present invention provide container connectionswhich maintain the sterility of the fluid pathway and which areintegrated into the drug container, and drug delivery pumps whichincorporate such integrated sterile fluid pathway connections to drugcontainers. Such devices are safe and easy to use, and are aestheticallyand ergonomically appealing for self-administering patients. The devicesdescribed herein incorporate features which make activation, operation,and lock-out of the device simple for even untrained users. The noveldevices of the present invention provide these desirable featureswithout any of the problems associated with known prior art devices.Certain non-limiting embodiments of the novel drug delivery pumps, fluidpathway connections, and their respective components are describedfurther herein with reference to the accompanying figures.

As used herein, the term “pump” is intended to include any number ofdrug delivery systems which are capable of dispensing a fluid to a userupon activation. Such drug delivery systems include, for example,injection systems, infusion pumps, bolus injectors, and the like. FIGS.1A-1C show an exemplary drug delivery device according to at least oneembodiment of the present invention. The drug delivery device may beutilized to administer delivery of a drug treatment into a body of auser. As shown in FIGS. 1A-1C, the drug pump 10 includes a pump housing12. Pump housing 12 may include one or more housing subcomponents whichare fixedly engageable to facilitate easier manufacturing, assembly, andoperation of the drug pump. For example, drug pump 10 includes a pumphousing 12 which includes an upper housing 12A and a lower housing 12B.The drug pump may further include an activation mechanism 14, a statusindicator 16, and a window 18. Window 18 may be any translucent ortransmissive surface through which the operation of the drug pump may beviewed. As shown in FIG. 1B, drug pump further includes a sterile fluidconduit (not visible), a drive mechanism 100 having a drug container 50,an insertion mechanism 200, a sterile fluid pathway connection 300, anda power and control system 400. One or more of the components of suchdrug pumps may be modular in that they may be, for example,pre-assembled as separate components and configured into position withinthe housing of the drug pump 10 during manufacturing.

The pump housing 12A, 12B contains all of the device components andprovides a means of removably attaching the device 10 to the skin of theuser. The pump housing 12A, 12B also provides protection to the interiorcomponents of the device 10 against environmental influences. The pumphousing 12A, 12B is ergonomically and aesthetically designed in size,shape, and related features to facilitate easy packaging, storage,handling, and use by users who may be untrained and/or physicallyimpaired. Furthermore, the external surface of the pump housing 12A, 12Bmay be utilized to provide product labeling, safety instructions, andthe like. Additionally, as described above, housing 12A, 12B may includecertain components, such as status indicator 16 and window 18, which mayprovide operation feedback to the user.

In at least one embodiment, the drug pump 10 provides an activationmechanism 14 that is displaced by the user to trigger the start commandto the power and control system 400. In a preferred embodiment, theactivation mechanism is a start button 14 that is located through thepump housing 12A, 12B, such as through an aperture between upper housing12A and lower housing 12B, and which contacts a control arm 40 of thepower and control system 400. In at least one embodiment, the startbutton 14 may be a push button, and in other embodiments, may be anon/off switch, a toggle, or any similar activation feature known in theart. The pump housing 12A, 12B also provides a status indicator 16 and awindow 18. In other embodiments, one or more of the activation mechanism14, the status indicator 16, the window 18, and combinations thereof maybe provided on the upper housing 12A or the lower housing 12B such as,for example, on a side visible to the user when the drug pump 10 isplaced on the body of the user. Housing 12A, 12B is described in furtherdetail hereinafter with reference to other components and embodiments ofthe present invention.

Drug pump is configured such that, upon activation by a user (such as bydepression) of the activation mechanism, the drug pump is initiated to:insert a fluid pathway, such as a needle or cannula, into the user;enable, connect, or open necessary fluid pathway connections between adrug container, a fluid pathway, and a sterile fluid conduit; and forcedrug fluid stored in the drug container through the fluid pathway andfluid conduit for delivery into a user. One or more optional safetymechanisms may be utilized, for example, to prevent premature activationof the drug pump. For example, an optional on-body sensor 24 (shown inFIGS. 1B and 1C) may be provided in at least one embodiment as a safetyfeature to ensure that the power and control system 400, and/or theactivation mechanism, cannot be engaged unless the drug pump 10 is incontact with the body of the user. In one such embodiment, the on-bodysensor 24 is located on the bottom of lower housing 12B where it maycome in contact with the user's body. Upon displacement of the on-bodysensor 24, depression of the activation mechanism is permitted.Accordingly, in at least one embodiment the on-body sensor 24 is amechanical safety mechanism, such as for example a mechanical lock out,that prevents triggering of the drug pump 10 by the activation mechanism14. In another embodiment, the on-body sensor may be anelectro-mechanical sensor such as a mechanical lock out that sends asignal to the power and control system 400 to permit activation. Instill other embodiments, the on-body sensor can be electrically basedsuch as, for example, a capacitive- or impedance-based sensor which mustdetect tissue before permitting activation of the power and controlsystem 400. These concepts are not mutually exclusive and one or morecombinations may be utilized within the breadth of the present inventionto prevent, for example, premature activation of the drug pump 10. In apreferred embodiment, the drug pump 10 utilizes one or more mechanicalon-body sensors. Additional integrated safety mechanisms are describedherein with reference to other components of the novel drug pumps.

Power and Control System:

The power and control system 400 may include a power source, whichprovides the energy for various electrical components within the drugpump, one or more feedback mechanisms, a microcontroller, a circuitboard, one or more conductive pads, and one or more interconnects. Othercomponents commonly used in such electrical systems may also beincluded, as would be appreciated by one having ordinary skill in theart. The one or more feedback mechanisms may include, for example,audible alarms such as piezo alarms and/or light indicators such aslight emitting diodes (LEDs). The microcontroller may be, for example, amicroprocessor. The power and control system 400 controls several deviceinteractions with the user and may interface with one or more othercomponents of the drug pump 10, such as the drive mechanism 100. In oneembodiment, the power and control system 400 interfaces with the controlarm 40 to identify when the on-body sensor 24 and/or the activationmechanism 14 have been activated. The power and control system 400 mayalso interface with the status indicator 16 of the pump housing 12A,12B, which may be a transmissive or translucent material which permitslight transfer, to provide visual feedback to the user. The power andcontrol system 400 may interface with the drive mechanism 100 and/or theintegrated sterile fluid pathway connection 300 and drug container 50through one or more interconnects to relay status indication, such asactivation, drug delivery, and/or end-of-dose, to the user. Such statusindication may be presented to the user via tactile feedback, such asvibration; auditory tones, such as through the audible alarms; and/orvia visual indicators, such as through the LEDs. In a preferredembodiment, the control interfaces between the power and control systemand the other components of the drug pump are not engaged or connecteduntil activation by the user. This is a desirable safety feature thatprevents accidental operation of the drug pump and may also maintain theenergy stored in the power source during storage, transport, and thelike.

The power and control system 400 may be configured to provide a numberof different status indicators to the user. For example, the power andcontrol system 400 may be configured such that after the on-body sensorand/or trigger mechanism have been pressed, the power and control system400 provides a ready-to-start status signal via the status indicator 16if device start-up checks provide no errors. After providing theready-to-start status signal and, in an embodiment with the optionalon-body sensor, if the on-body sensor remains in contact with the bodyof the user, the power and control system 400 will power the drivemechanism 100 to begin delivery of the drug treatment through theintegrated sterile fluid pathway connection 300 and sterile fluidconduit 30. In a preferred embodiment of the present invention, theinsertion mechanism 200 and the drive mechanism 100 may be caused toactivate directly by user operation of the activation mechanism 14. Theintegrated sterile fluid pathway connection is connected (i.e., thefluid pathway is opened) by the pneumatic force of the drug fluid withinthe drug container 50 created by activation of the drive mechanism 100,as is detailed further herein. During the drug delivery process, thepower and control system 400 is configured to provide a dispensingstatus signal via the status indicator 16. After the drug has beenadministered into the body of the user and after the end of anyadditional dwell time, to ensure that substantially the entire dose hasbeen delivered to the user, the power and control system 400 may providean okay-to-remove status signal via the status indicator 16. This may beindependently verified by the user by viewing the drive mechanism anddelivery of the drug dose within the drug container through the window18 of the pump housing 12A, 12B. Additionally, the power and controlsystem 400 may be configured to provide one or more alert signals viathe status indicator 16, such as for example alerts indicative of faultor operation failure situations.

Other power and control system configurations may be utilized with thenovel drug pumps of the present invention. For example, certainactivation delays may be utilized during drug delivery. As mentionedabove, one such delay optionally included within the systemconfiguration is a dwell time which ensures that substantially theentire drug dose has been delivered before signaling completion to theuser. Similarly, activation of the device may require a delayeddepression (i.e., pushing) of the activation mechanism 14 of the drugpump 10 prior to drug pump activation. Additionally, the system mayinclude a feature which permits the user to respond to the end-of-dosesignals and to deactivate or power-down the drug pump. Such a featuremay similarly require a delayed depression of the activation mechanism,to prevent accidental deactivation of the device. Such features providedesirable safety integration and ease-of-use parameters to the drugpumps. An additional safety feature may be integrated into theactivation mechanism to prevent partial depression and, therefore,partial activation of the drug pumps. For example, the activationmechanism and/or power and control system may be configured such thatthe device is either completely off or completely on, to prevent partialactivation. Such features are described in further detail hereinafterwith regard to other aspects of the novel drug pumps.

Insertion Mechanism:

A number of insertion mechanisms may be utilized within the drug pumpsof the present invention. In at least one embodiment, the insertionmechanism 200 includes an insertion mechanism housing having one or morelockout windows, and a base for connection to the assembly platformand/or pump housing (as shown in FIG. 1B and FIG. 1C). The connection ofthe base to the interior of the pump housing 12A, 12B may be, forexample, such that the bottom of the base is permitted to pass-through ahole in the bottom housing 12B to permit direct contact of the base tothe body of the user. In such configurations, the bottom of the base 252may include a sealing membrane 254 that is removable prior to use of thedrug pump 10. The insertion mechanism may further include one or moreinsertion biasing members, a needle, a retraction biasing member, acannula, and a manifold. The manifold may connect to sterile fluidconduit 30 to permit fluid flow through the manifold, the needle and/orcannula, and into the body of the user during drug delivery.

As used herein, “needle” is intended to refer to a variety of needlesincluding but not limited to conventional hollow needles, such as arigid hollow steel needles, and solid core needles commonly referred toas a “trocars.” In a preferred embodiment, the needle is a 27 gaugesolid core trocar and in other embodiments, the needle may be any sizeneedle suitable to insert the cannula for the type of drug and drugadministration (e.g., subcutaneous, intramuscular, intradermal, etc.)intended. A sterile boot may be utilized within the needle insertionmechanism. The sterile boot is a collapsible sterile membrane that is infixed engagement at a proximal end with the manifold and at a distal endwith the base. In at least on embodiment, the sterile boot is maintainedin fixed engagement at a distal end between base and insertion mechanismhousing. Base includes a base opening through which the needle andcannula may pass-through during operation of the insertion mechanism, aswill be described further below. Sterility of the cannula and needle aremaintained by their initial positioning within the sterile portions ofthe insertion mechanism. Specifically, as described above, needle andcannula are maintained in the sterile environment of the manifold andsterile boot. The base opening of base 252 may be closed fromnon-sterile environments as well, such as by for example a sealingmembrane 254 (shown in FIG. 1C).

According to at least one embodiment of the present invention, theinsertion mechanism is substantially similar to that described inInternational Patent Application No. PCT/US2012/053174, which isincluded by reference herein in its entirety for all purposes. Theinsertion mechanism is initially locked into a ready-to-use stage bylockout pin(s) which are initially positioned within lockout windows ofthe insertion mechanism housing. In this initial configuration,insertion biasing member and retraction biasing member are each retainedin their compressed, energized states. As shown in FIG. 1B, the lockoutpin(s) 208 may be directly displaced by user depression of theactivation mechanism 14. As the user disengages any safety mechanisms,such as an optional on-body sensor 24, the activation mechanism 14 maybe depressed to initiate the drug pump. Depression of the activationmechanism 14 may directly cause translation or displacement of controlarm 40 and directly or indirectly cause displacement of lockout pin(s)208 from their initial position within corresponding locking windows ofinsertion mechanism 200. Displacement of the lockout pin(s) 208 permitsinsertion biasing member to decompress from its initial compressed,energized state. This decompression of the insertion biasing memberdrives the needle and the cannula into the body of the user. At the endof the insertion stage, the retraction biasing member is permitted toexpand in the proximal direction from its initial energized state. Thisaxial expansion in the proximal direction of the retraction biasingmember retracts the needle while maintaining the cannula in fluidcommunication with the body of the user. Accordingly, the insertionmechanism may be used to insert a needle and cannula into the user and,subsequently, retract the needle while retaining the cannula in positionfor drug delivery to the body of the user. In an alternative embodiment,the needle may be retained in fluid communication within the body withor without the presence of a flexible cannula. A number of insertionmechanisms may be utilized, as would readily be appreciated by anordinarily skilled artisan.

Drive Mechanism:

A number of drive mechanisms may be utilized to force fluid from a drugcontainer for delivery into the body of a user. In one such embodiment,the drive mechanism 100 may be substantially similar to that describedin International Patent Application No. PCT/US2012/053241, which isincluded by reference herein in its entirety for all purposes. As shownin FIG. 2A, a drug container may have a drug chamber 21 within thebarrel 58 between a sliding pierceable seal 56 and a plunger seal 60.The drug chamber 21 may contain a drug fluid for delivery throughintegrated sterile fluid pathway connection, the insertion mechanism,and drug pump into the body of the user. The seals described herein maybe comprised of a number of materials but are, in a preferredembodiment, comprised of one or more elastomers or rubbers. The drivemechanism 100 may contain one or more drive biasing members to drive theplunger seal 60. The components of the drive mechanism function to forcea fluid from the drug chamber 21 out through the sliding pierceableseal, or preferably through the piercing member 330 of the fluid pathwayconnection 300, for delivery through the fluid pathway connection 300,sterile fluid conduit 30, and insertion mechanism 200 into the body ofthe user. For clarity, the piercing member 330 may be an aspect of fluidconduit 30 or may be a separate component from fluid conduit 30, aswould readily be appreciated by one having ordinary skill in the art.

In one particular embodiment, the drive mechanism 100 employs one ormore compression springs as the biasing member(s). Upon activation ofthe drug pump by the user, the power and control system 400 may beactuated to directly or indirectly release the compression spring(s)from an energized state. Upon release, the compression spring(s) maybear against and act upon the plunger seal 60 to force the fluid drugout of the drug chamber 21 of the drug container. As the plunger seal 60asserts a force on the drug fluid, pneumatic pressure builds bycompression of the drug fluid and the force is relayed to the slidingpierceable seal 56. The sliding pierceable seal 56 is caused to slidetowards the cap 52, causing it to be pierced by the piercing memberretained within the integrated sterile fluid pathway connection 300.Accordingly, the integrated sterile fluid pathway connection 300 isconnected (i.e., the fluid pathway is opened) by the pneumatic force ofthe drug fluid within the drug chamber 21 created by activation of thedrive mechanism 100, as is detailed further herein. Once the integratedsterile fluid pathway connection 300 is connected or opened, drug fluidis permitted to flow from the drug container, through the integratedsterile fluid pathway connection, sterile fluid conduit, and insertionmechanism, and into the body of the user for drug delivery. In at leastone embodiment, the fluid flows through only a manifold and a cannulaand/or needle of the insertion mechanism, thereby maintaining thesterility of the fluid pathway before and during drug delivery. Suchcomponents and their functions are described in further detailhereinafter.

The components of the drive mechanism 100, upon activation, may be usedto drive axial translation in the distal direction of the plunger sealof the drug container. Optionally, the drive mechanism 100 may includeone or more compliance features which enable additional axialtranslation of the plunger seal to, for example, ensure thatsubstantially the entire drug dose has been delivered to the user andmake sure that the feedback contact mechanisms have connected.Additionally or alternatively, the plunger seal and/or the slidingpierceable seal may have some compressibility permitting a compliancepush of drug fluid from the drug container. The drive mechanism 100 maysimilarly include one or more status indication mechanisms, such asinterconnects and contacts, to measure and communicate the status of thedrive mechanism before, during, and after operation of the drivemechanism and the device to the user. Such components and functionalityare described in further detail herein. Furthermore, the drive mechanism100 may include one or more safety mechanisms, such as prematureactivation prevention mechanisms, to enhance the safety and usability ofthe mechanism and the device.

Integrated Sterile Fluid Pathway Connection:

The novel embodiments of the present invention provide integratedsterile fluid pathway connections and drug containers, and drug pumpswhich utilize such connections which are capable of maintaining thesterility of the fluid pathway before, during, and after operation ofthe device, and which enable active safety controls for the device.Integration of the fluid pathway connection into a portion of the drugcontainer helps ensure container integrity and sterility of the fluidpathway. Additionally, by integrating the sterile fluid pathwayconnection into a portion of the drug container, the connection forfluid transfer can be controlled by the user (i.e., user-activated) andenabled by the function of the drive mechanism. Accordingly,user-activation steps and the internal operation of the drug pump can begreatly simplified by the novel integrated sterile fluid pathwayconnections of the present invention.

In one embodiment, the fluid pathway connection 300 includes a sterilefluid conduit 30, a piercing member 330, a connection hub 310, and asliding pierceable seal 56. As shown in FIGS. 2A and 2B, the fluidpathway connection 300 may optionally include a seal mount 340 uponwhich the sliding pierceable seal 56 may be mounted to interface withconnection hub 310. A permeable, semi-permeable, or porous membrane,such as a filter 309, may be utilized to allow venting of air fromwithin the fluid pathway connection 300 during operation of the device.The filter 309 may be attached, mounted, bonded, over-molded, co-molded,pre-formed, or otherwise connected to enclose the sterile cavity 311within the connection hub 310. The term “enclose” or “enclosure” is usedherein to define at least a semi-permeable or porous confined area thatis capable of being sterilized, evacuated by vacuum, and vented, but notpenetrable by microorganisms, contaminants, or other undesirableenvironmental factors. For example, the filter 309 may be over-molded atleast partially within the connection hub 310 to separate the sterilecavity 311 from the outside environment. The filter is a membrane,preferably a semi-permeable membrane, which allows the venting of airduring the actuation of the sliding pierceable seal 56, the fluidpathway connection 300, and device 10. While the filter may be permeableto sterilization methods, which would readily be appreciated by onehaving ordinary skill in the art, the filter may be utilized to maintaina sterile barrier to prevent exposure of the piercing member 330 tomicroorganisms, contaminants, or other undesirable environmentalfactors.

Additionally, the fluid pathway connection 300 may optionally includeone or more gaskets, O-rings, or other sealing members, such as gasket320 compressed to seal between barrel 58, connection hub 310, and cap52. The cap 52 may be a separate component or may be an aspect ofconnection hub 310 capable of mounting to the barrel 58. As shown inFIG. 1C, the fluid pathway connection 300 may be attached to (i.e.,integrated with) a drug container 50 and mounted, by a number of knownmethods, either fixedly or removably to an assembly platform or housingof the drug pump. The assembly platform may be a separate component fromthe housing, or may be a unified component of the housing such as apre-formed mounting aspect on the interior surfaces of the housing. Ineither configuration, the sterility of the fluid pathway is maintained,the pathway for fluid flow is not connected until desired by the user,and user-initiated activation causes the connection of the drug chamberand the fluid pathway connection. The fluid pathway connection may,optionally, further include one or more separate flow restrictors and/orone or more of piercing member 330 and fluid conduit 30 may additionallyfunction as flow restrictors.

Upon proper activation of the device 10 by the user, the fluid pathwayconnection 300 is connected to the drug container 50, thereby enablingfluid flow from the drug chamber 21 (as may be forced by the drivemechanism 100), through the fluid pathway connection 300, the fluidconduit 30, the insertion mechanism 200 and into the body of the user.Such connection between the fluid pathway connection 300 and the drugchamber 21 may be facilitated by a piercing member 330, such as aneedle, penetrating a sliding pierceable seal 56 (shown in thetransition between FIGS. 4A and 4B). As the plunger seal 60 asserts aforce on the drug fluid, pneumatic pressure builds by compression of thedrug fluid and the force is relayed to the sliding pierceable seal 56.The sliding pierceable seal 56 is caused to slide towards the cap 52,causing it to be pierced by the piercing member retained within theintegrated sterile fluid pathway connection 300. Accordingly, theintegrated sterile fluid pathway connection 300 is connected (i.e., thefluid pathway is opened) by the pneumatic force of the drug fluid withinthe drug chamber 21 created by activation of the drive mechanism 100, asis detailed further herein.

The sterility of the fluid pathway connection is initially maintained byperforming the connection within a sterile cavity 311 between connectionhub 310, sliding pierceable seal 56, and optionally seal mount 340. Inat least one embodiment, the sterility of cavity 311 is maintained by afilter 309 connected to, or part of, the connection hub 310. The filter309 may be, for example, a semi-permeable membrane that allows theventing of air during the actuation and translation of the slidingpierceable seal 56. While the filter may be permeable to sterilizationmethods, which would readily be appreciated by one having ordinary skillin the art, the filter may be utilized to maintain a sterile barrier toprevent expose of the piercing member 330 to microorganisms,contaminants, or other undesirable environmental factors. Uponsubstantially simultaneous activation of the insertion mechanism 200,the fluid pathway between drug chamber 21 and insertion mechanism 200 iscomplete to permit drug delivery into the body of the user. Because thefluid pathway connection is not in fluid connection or communicationwith the drug chamber until activation of the drug pump and drivemechanism, fluid flow from the drug container is prevented until desiredby the user. This provides an important safety feature to the user whilealso maintaining the container integrity of the drug container andsterility of the fluid pathway.

FIGS. 2A and 2B show an initial configuration of the sterile fluidpathway connection 300 integrated with a drug container 50 having a drugchamber 21 and a plunger seal 60. The fluid pathway connection 300 maybe mounted, connected, or otherwise attached to the drug container 50 atan end opposite the plunger seal 60. At least in an initialconfiguration, a piercing member 330 is maintained within a sterilecavity 311 with a proximal end adjacent to, or contacting, a slidingpierceable seal 56 of the fluid pathway connection 300. Preferably, thesterility of cavity 311 and piercing member 330 is maintained by afilter 309 which may be between the sterile cavity 311 and the outsideenvironment. In at least one embodiment, the filter 309 is connected to,or part of, the connection hub 310 to enclose the sterile cavity 311from the outside environment. Accordingly, the fluid pathway connection300 of the present invention, in at least one embodiment, is mounted toand integrated with a drug container 50. The piercing member 330 may bea number of cannulas or conduits, such as rigid needles, and may becomprised of a number of materials, such as steel. In at least oneembodiment, the piercing member 330 is a rigid steel needle. The slidingpierceable seal 56 may be mounted directly to, and translatable upon, aconnection post 310A of the connection hub 310. Such an arrangementpermits the sliding pierceable seal 56 to translate towards the cap 52but not towards the plunger seal 60. This is a desirable feature whichpermits the drug chamber 21 of the drug container 50 to be evacuated,such as by vacuum, prior to filling with a drug fluid withoutcompromising the function of the sterile fluid pathway connection 300.

As the device is activated and the drive mechanism pushes the plungerseal 60 to begin drug delivery, pneumatic pressure builds up in the drugfluid within the drug chamber 21. The pneumatic pressure applies a forceto the sliding pierceable seal 56 causing it to translate uponconnection post 310A towards cap 52. This translation of the slidingpierceable seal 56 and the substantially fixed position of the piercingmember 330 causes piercing member 330 to pierce the sliding pierceableseal 56 at seal barrier 56C, thereby opening or otherwise connecting thefluid pathway between the drug chamber 21, the piercing member 330, andthe fluid conduit 30. In an initial position, the distal end of thepiercing member 330 may reside adjacent to, or in contact with, the sealbarrier 56C of the sliding pierceable seal 56 to, for example, minimizethe distance of translation of the sliding pierceable seal 56 to becomepierced and open the drug container to the fluid pathway. In oneparticular embodiment, the distal end of the piercing member 330 mayreside at least partially within the seal barrier 56C of the slidingpierceable seal 56, yet not fully passing there-through until activationof the device by the user.

In at least one embodiment of the present invention, as shown in FIGS.2A, 2B, 5A, and 5B, among others, a seal mount 340 may be utilized tomount the sliding pierceable seal 56 upon and to slidably engage theconnection post 310A of the connection hub 310. The sliding pierceableseal 56 may be removably attached to the seal mount 340 by a number ofmeans known in the art such as, for example, removable snap-fitengagement between seal ledge 56B and corresponding seal mount rim 340B.Similarly, the seal mount 340 may be slidably attached to connection hub310 at connection post 310A. A number of means known in the art may beutilized to facilitate this slidable attachment such as, for example,engagement between connection prongs 310A of the connection hub 310 andcorresponding connection rim 340A of the seal mount 340. Thesecomponents are more clearly visible in FIGS. 3A, 3B, and 5B. Such anarrangement permits the sliding pierceable seal 56 and the seal mount340 to translate towards the cap 52 but not towards the plunger seal 60.This is a desirable feature which permits the drug chamber 21 of thedrug container 50 to be evacuated, such as by vacuum, prior to fillingwith a drug fluid without compromising the function of the sterile fluidpathway connection 300.

As is visible in the embodiment shown in FIGS. 2A, 2B, 5A, and 5B, amongothers, the fluid conduit 30 may be connected directly to piercingmember 330. Alternatively, as shown in FIGS. 5C and 5D, the fluidconduit 30 may be connected to a header 310C of the connection hub 310at conduit port 312. The piercing member 330 may reside within header310C, such as within a chamber 313. Header 310C may also have a vacuumport 310D with a channel 310E that leads into chamber 313. Conduit port312 and vacuum port 310D may contain membranes or seals, such as one-wayseals, which permit fluid flow out of chamber 313 through the respectiveports but not permit fluid flow into the chamber 313 through said ports.Additionally, or alternatively, conduit port 312 and vacuum port 310Dmay be plugged at certain points of assembly or operation. For example,vacuum port 310D may be utilized to evacuate the chamber 313, thepiercing member 330, and the sterile cavity 311 during manufacturing,assembly, or at any point prior to operation of the device; and thenvacuum port 310D may be plugged after the evacuation has been completed.

FIG. 3A shows an exploded view of an integrated sterile fluid pathwayconnection and drug container, exploded along a longitudinal axis “A,”according to at least one embodiment of the present invention. FIG. 3Bshows a cross-sectional exploded view of the same embodiment. Asdetailed herein, the sterile fluid pathway connection 300 may beintegrated into the drug container 50 at an end opposite the plungerseal 60. An exemplary drive mechanism 100, as detailed above, is shownin these figures to clarify the orientation of these components in atleast one embodiment of the present invention. The components of thenovel sterile fluid pathway connection 300 may be pre-assembled, toappear as shown in FIG. 5A, and attached, mounted, connected, orotherwise mated with the drug container 50. Alternatively, thecomponents of the sterile fluid pathway connection 300 may be assembleddirectly into the drug container 50. As would be readily appreciated byan ordinary skilled artisan, a number of glues or adhesives, or otherconnection methods such as snap-fit, interference fit, screw fit, fusionjoining, welding, ultrasonic welding, laser welding, and mechanicalfastening, and the like may optionally be utilized to engage one or moreof the components described herein. For example, a glue may be utilizedbetween the distal end of the barrel 58 and the connection hub 310and/or the optional gasket 320. Additionally or alternatively, thecomponents of the sterile fluid pathway connection 300 may be mounted tobarrel 58 and held in place by crimping cap 52 to a distal aspect ofbarrel 58, such as to a flanged aspect of barrel 58.

FIGS. 4A-4C show a cross-sectional view of an integrated sterile fluidpathway connection and drug container as it progresses through thestages of use. FIG. 4A shows the sterile fluid pathway connection 300prior to user activation of the device by the user. The piercing member330 is initially maintained within a sterile cavity 311 with a proximalend adjacent to, or contacting, a sliding pierceable seal 56 of thefluid pathway connection 300. The sliding pierceable seal 56 may beremovably attached to the seal mount 340 by a number of means known inthe art such as, for example, removable snap-fit engagement between sealledge 56B and corresponding seal mount rim 340B. Similarly, the sealmount 340 may be slidably attached to connection hub 310 at connectionpost 310A. In at least one embodiment, the sterility of cavity 311 ismaintained by a filter 309. The filter 309 may be a permeable,semi-permeable, or porous membrane to allow venting of air from withinthe fluid pathway connection 300 during operation of the device andactuation and translation of the sliding pierceable seal 56. The filter309 may be attached, mounted, bonded, over-molded, co-molded,pre-formed, or otherwise connected to enclose the sterile cavity 311within the connection hub 310. For example, the filter 309 may beover-molded at least partially within the connection hub 310 to separatethe sterile cavity 311 from the outside environment. While the filtermay be permeable to sterilization methods, which would readily beappreciated by one having ordinary skill in the art, the filter may beutilized to maintain a sterile barrier to prevent exposure of thepiercing member 330 to microorganisms, contaminants, or otherundesirable environmental factors.

Whether or not the optional seal mount 340 is utilized in the sterilefluid connection 300, a distance D1 initially exists between theconnection hub 310 and the sliding pierceable seal 56 and/or seal mount340, as shown in FIG. 4A. A number of means known in the art may beutilized to facilitate this slidable attachment such as, for example,engagement between connection prongs 310A of the connection hub 310 andcorresponding connection rim 340A of the seal mount 340. Such anarrangement permits the sliding pierceable seal 56 and the seal mount340 to translate towards the cap 52 but not towards the plunger seal 60.This is a desirable feature which permits the drug chamber 21 of thedrug container 50 to be evacuated at the proximal end, such as byvacuum, prior to filling with a drug fluid without compromising thefunction of the sterile fluid pathway connection 300. After filling thedrug chamber with a drug fluid, a plunger seal 60 may be inserted intothe drug container 50 to seal the proximal end. A drive mechanism 100may then be attached to the proximal end of the drug container 50 or,alternatively, these components may be caused to come into contact uponassembly into the drug pump. As the device is activated and the drivemechanism 100 pushes the plunger seal 60 to begin drug delivery,pneumatic pressure builds up in the drug fluid within the drug chamber21. The pneumatic pressure applies a force to the sliding pierceableseal 56 causing it to translate, with seal mount 340 when one isutilized, upon connection post 310A towards cap 52 (i.e., the distalend). As shown in FIG. 4B, this translation of the sliding pierceableseal 56 (in the direction of the hatched arrow) and the substantiallyfixed position of the piercing member 330 closes the distance D1 andcauses piercing member 330 to pierce the sliding pierceable seal 56 atmembrane 56A, thereby opening or otherwise connecting the fluid pathwaybetween the drug chamber 21, the piercing member 330, and the fluidconduit 30. Once the fluid pathway is opened or connected, translationof the plunger seal 60 in the distal direction by the drive mechanism100 causes drug fluid within drug chamber 21 to be forced throughpiercing member 330 and fluid conduit 30 for drug delivery to the user.A needle insertion mechanism, as described herein, may be connected atthe other end of the fluid conduit 30 to insert a needle into the bodyof the user to facilitate fluid transfer to the user. FIG. 4C shows thecomponents of the drive mechanism 100, drug container 50, and sterilefluid pathway connection 300 after substantially all of the drug fluidhas been pushed out of the drug container 50. Because of the noveldesign of the fluid pathway connections 300 of the present invention andtheir integration within drug containers 50, sterility of the fluidpathway is maintained throughout transport, storage, and operation ofthe device; user-activation of the device is simplified; and the fluidpathway is only connected when desired by the user.

The novel integrated sterile fluid pathway connections of the presentinvention may additionally incorporate status indication into the drugdose delivery. Such status indication features may be incorporated intothe drive mechanism 100, as described in International PatentApplication No. PCT/US2012/053241 and incorporate herein by reference.Additionally or alternatively, such status indication features may beincorporated into the components of the sterile fluid pathway connectionthemselves. In one embodiment, one or more interconnects 61 arecontained within, or proximal of, plunger seal 60. At the end of drugdelivery, shown in FIG. 4C, the piercing member 330, itself, may beutilized to contact the, and/or as a contact for, interconnect 61 toopen, close, or otherwise create a signal to the power and controlsystem to provide feedback to the user. In another embodiment, one ofeither the interconnects 61 or the contacts 62 are contained within, orproximal of, plunger seal 60, while the other is contained within ordistal of sliding pierceable seal 56. At the end of drug delivery, theinterconnects and corresponding contacts are close enough to permit asignal to be sent to the power and control system to provide feedback tothe user. A number of known interconnects and contacts, or similarcomponents, are known in the art and may be utilized within the novelembodiments disclosed herein. As would readily be appreciated by onehaving ordinary skill in the art, a vast range of magnets, sensors,coils, and the like may be utilized to connect, transmit, or relay asignal for user feedback. Generally, any RLC circuit systems having aresistor, an inductor, and a capacitor, connected in series or inparallel, may be utilized for this purpose. For example, Hall effectsensors; giant magneto resistance (GMR) or magnetic field sensors;optical sensors; capacitive or capacitance change sensors; ultrasonicsensors; and/or linear travel, LVDT, linear resistive, or radiometriclinear resistive sensors may be utilized as interconnects andcorresponding contacts used to permit a signal to be sent to the powerand control system to provide feedback to the user. The location of thecontacts and interconnects may be interchanged or in a number of otherconfigurations which permit completion of an electrical circuit orotherwise permit a transmission between the components.

By use of one or more status switch interconnects and one or morecorresponding electrical contacts, the status of the drive mechanismbefore, during, and after operation can be relayed to the power andcontrol system to provide feedback to the user. Such feedback may betactile, visual, and/or auditory, as described above, and may beredundant such that more than one signals or types of feedback areprovided to the user during use of the device. As described above, in atleast one embodiment an end-of-dose status indication may be provided tothe user once the status switch interconnect 132 is caused to contactelectrical contact 134 at the end of axial travel of the plunger seal 60within the barrel 58 of the drug container 50.

Additionally, the embodiments of the present invention provideend-of-dose compliance to ensure that substantially the entire drug dosehas been delivered to the user and that the status indication featureshave been properly contacted to provide accurate feedback to the user.Through these mechanisms, confirmation of drug dose delivery canaccurately be provided to the user or administrator. Accordingly, thenovel devices of the present invention alleviate one or more of theproblems associated with prior art devices, such as those referred toabove. Optionally, the drive mechanism 100 may include one or morecompliance features which enable additional axial translation of theplunger seal 60 to, for example, ensure that substantially the entiredrug dose has been delivered to the user and make sure that the feedbackcontact mechanisms have connected. For example, in one embodiment of thepresent invention, as will be described further below, the drivemechanism 100 may be configured to drive further axial translation of atleast a portion of the plunger seal 60 for a compliance push of theplunger seal, and/or of drug fluid, from the drug container.Additionally or alternatively, the plunger seal 60, itself, may havesome compressibility permitting a compliance push. For example, when apop-out plunger seal is employed, i.e., a plunger seal that isdeformable from an initial state, the plunger seal may be caused todeform or “pop-out” to provide a compliance push. Similarly, the plungerseal may be porous, compressible, deformable, or the like to itself becapable of providing a compliance push.

FIGS. 6A-6D show a cross-sectional view of an integrated sterile fluidpathway connection and drug container according to another embodiment ofthe present invention, as it progresses through the stages of operation.The embodiment shown in FIGS. 6A-6D provides end-of-dose indicationand/or additional compliance travel. FIG. 6A shows the configurationprior to user activation while FIG. 6B shows the configuration with thefluid pathway connected. FIG. 6C shows the configuration substantiallyat the end of drug delivery and FIG. 6D shows the configuration afteradditional compliance travel and/or end-of-dose indication. As visiblein FIGS. 6A-6D, the interconnects 102 and electrical contacts 104 may belocated between the drive mechanism 100 and the plunger seal 60 in atleast one embodiment of the present invention. A modified plunger seal60 may be utilized to interface with a piston 101 and piston tip 101Acomponent of the drive mechanism 100, to provide a compliance push orcompliance travel at or near the end of operation.

Initially, as shown in FIG. 6A, a drug fluid may be contained withindrug chamber 21 for delivery to the user. In an initial configuration,the sterile fluid pathway connection 300 is closed as described above.As the device is activated and the drive mechanism pushes the plungerseal 60 to begin drug delivery, pneumatic pressure builds up in the drugfluid within the drug chamber 21. The pneumatic pressure applies a forceto the sliding pierceable seal 56 causing it to translate uponconnection post 310A towards cap 52 (in the direction of the hatchedarrow in FIG. 6B). This translation of the sliding pierceable seal 56and the substantially fixed position of the piercing member 330 causespiercing member 330 to pierce the sliding pierceable seal 56 at sealbarrier 56C, thereby opening or otherwise connecting the fluid pathwaybetween the drug chamber 21, the piercing member 330, and the fluidconduit 30. In an initial position, the distal end of the piercingmember 330 may reside adjacent to, or in contact with, the seal barrier56C of the sliding pierceable seal 56 to, for example, minimize thedistance of translation of the sliding pierceable seal 56 to becomepierced and open the drug container to the fluid pathway. In oneparticular embodiment, the distal end of the piercing member 330 mayreside at least partially within the seal barrier 56C of the slidingpierceable seal 56, yet not fully passing there-through until activationof the device by the user. As the drive mechanism 100 continues to applyforce on the plunger seal 60 and translate the plunger seal 60 towardsthe cap 52, drug fluid is forced out of drug chamber 21 through thepiercing member 330 for delivery to the user (as shown in FIG. 6B). Atthis stage of operation, a distance D3 is maintained betweeninterconnects 102 and contacts 104. FIG. 6C shows the configurationsubstantially at the end of drug delivery. To ensure that the drug fluidhas been delivered, the plunger seal 60 may be compressible and/ordeformable to provide further axial travel. This further axial travel isshown in the transition between FIG. 6C and FIG. 6D as a deformation ofplunger seal 60, for example, at membrane 60A. Thus further axialtranslation of the plunger seal 60 also closes distance D3 and permitsinterconnects 102 and electrical contacts 104 to contact or otherwisepermit a signal to be sent to the power and control system to providefeedback to the user. Accordingly, the embodiments of the presentinvention may be utilized to provide compliance travel and/orend-of-dose indication.

FIGS. 7A-7D show a cross-sectional view of an integrated sterile fluidpathway connection and drug container according to yet anotherembodiment of the present invention, as it progresses through the stagesof operation. The embodiment shown in FIGS. 7A-7D provides end-of-doseindication and/or additional compliance travel. As visible in FIGS.7A-7D, the interconnects 102 and electrical contacts 104 may be locatedbetween the sliding pierceable seal 56 and the connection hub 310, suchas between the optional seal mount 340 and the connection hub 310, in atleast one embodiment of the present invention. Initially, as shown inFIG. 7A, a drug fluid may be contained within drug chamber 21 fordelivery to the user. In an initial configuration, the sterile fluidpathway connection 300 is closed as described above. As the device isactivated and the drive mechanism pushes the plunger seal 60 to begindrug delivery, pneumatic pressure builds up in the drug fluid within thedrug chamber 21. The pneumatic pressure applies a force to the slidingpierceable seal 56 causing it to translate upon connection post 310Atowards cap 52 (in the direction of the hatched arrow in FIG. 7B). Thistranslation of the sliding pierceable seal 56 and the initially fixedposition of the piercing member 330 causes piercing member 330 to piercethe sliding pierceable seal 56 at seal barrier 56C, thereby opening orotherwise connecting the fluid pathway between the drug chamber 21, thepiercing member 330, and the fluid conduit 30. The sliding pierceableseal 56 and other components of the sterile fluid pathway connection 300may be configured to translate only an initial distance to open orconnect the fluid pathway while remaining a distance (shown as distanceD5 in FIG. 7B) apart from connection hub 310.

As the drive mechanism 100 continues to apply force on the plunger seal60 and translate the plunger seal 60 towards the cap 52, drug fluid isforced out of drug chamber 21 through the piercing member 330 fordelivery to the user (as shown in FIG. 7B). FIG. 7C shows theconfiguration substantially at the end of drug delivery. To ensure thatthe drug fluid has been delivered, the plunger seal 60 may becompressible and/or deformable to provide further axial travel. Thisfurther axial travel is shown in the transition between FIG. 7C and FIG.7D which closes the distance D5 previously shown in FIG. 7B. Thusfurther axial translation of the plunger seal 60 and sliding pierceableseal 56 also permits interconnects 102 and electrical contacts 104 tocontact or otherwise permit a signal to be sent to the power and controlsystem to provide feedback to the user. Accordingly, the embodiments ofthe present invention may be utilized to provide compliance traveland/or end-of-dose indication.

As described above, the location of the contacts and interconnects maybe interchanged or in a number of other configurations which permitcompletion of an electrical circuit or otherwise permit a transmissionbetween the components. For example, the embodiment shown in FIGS. 7A-7Dmay be modified to permit the piercing member 330 to detach, break-away,or otherwise translate in the direction of the cap 52 after thecompliance travel to trigger an end-of-dose indication. Other componentsof the sterile fluid pathway connection may similarly be utilized formultiple functions. Alternatively, other optional components may beutilized within the novel embodiments of the present invention. Forexample, one or more optional flow restrictors may be utilized withinthe configurations of the fluid pathway connection described herein. Inat least one embodiment, a flow restrictor may be utilized at theconnection between the piercing member 330 and the fluid conduit 30. Thedrug pump is capable of delivering a range of drugs with differentviscosities and volumes. The drug pump is capable of delivering a drugat a controlled flow rate (speed) and/or of a specified volume. In oneembodiment, the drug delivery process is controlled by one or more flowrestrictors within the fluid pathway connection and/or the sterile fluidconduit. In other embodiments, other flow rates may be provided byvarying the geometry of the fluid flow path or delivery conduit, varyingthe speed at which a component of the drive mechanism advances into thedrug container to dispense the drug therein, or combinations thereof. Inat least one embodiment of the present invention, the connection hubitself may be utilized as part of the fluid path and may, optionally,function as a flow restrictor.

Certain optional standard components or variations of sterile pathwayconnection 300 or drug pump 10 are contemplated while remaining withinthe breadth and scope of the present invention. For example, upper orlower housings may optionally contain one or more transparent ortranslucent windows 18, as shown in FIG. 1A, to enable the user to viewthe operation of the drug pump 10 or verify that drug dose hascompleted. Additionally, the drug pump 10 may contain an adhesive patch26 and a patch liner 28 on the bottom surface of the housing 12. Theadhesive patch 26 may be utilized to adhere the drug pump 10 to the bodyof the user for delivery of the drug dose. As would be readilyunderstood by one having ordinary skill in the art, the adhesive patch26 may have an adhesive surface for adhesion of the drug pump to thebody of the user. The adhesive surface of the adhesive patch 26 mayinitially be covered by a non-adhesive patch liner 28, which is removedfrom the adhesive patch 26 prior to placement of the drug pump 10 incontact with the body of the user. Removal of the patch liner 28 mayfurther remove the sealing membrane 254 of the insertion mechanism 200,opening the insertion mechanism to the body of the user for drugdelivery (as shown in FIG. 1C). Furthermore, as described above, anumber of flow restrictors may be optionally utilized to modify the flowof fluid within the fluid pathway connection.

Similarly, one or more of the components of fluid pathway connection 300and drug pump 10 may be modified while remaining functionally within thebreadth and scope of the present invention. For example, as describedabove, while the housing of drug pump 10 is shown as two separatecomponents upper housing 12A and lower housing 12B, these components maybe a single unified component. As discussed above, a glue, adhesive, orother known materials or methods may be utilized to affix one or morecomponents of the fluid pathway connection and/or drug pump to eachother. For example, the upper housing and lower housing may be separatecomponents affixed together by a glue or adhesive, a screw fitconnection, an interference fit, fusion joining, welding, ultrasonicwelding, laser welding, and mechanical fastening, and the like; or theupper housing and lower housing may be a single unified component. Suchstandard components and functional variations would be appreciated byone having ordinary skill in the art and are, accordingly, within thebreadth and scope of the present invention.

It will be appreciated from the above description that the fluid pathwayconnections and drug pumps disclosed herein provide an efficient andeasily-operated system for automated drug delivery from a drugcontainer. The novel devices of the present invention provide containerconnections which maintain the sterility of the fluid pathway and whichare integrated into the drug container, and drug delivery pumps whichincorporate such integrated sterile fluid pathway connections to drugcontainers. Such devices are safe and easy to use, and are aestheticallyand ergonomically appealing for self-administering patients. The devicesdescribed herein incorporate features which make activation, operation,and lock-out of the device simple for even untrained users. The noveldevices of the present invention provide these desirable featureswithout any of the problems associated with known prior art devices.Because the fluid path is disconnected until drug delivery is desired bythe user, the sterility of the fluid pathway connection, the drugcontainer, the drug fluid, and the device as a whole is maintained.These aspects of the present invention provide highly desirable storage,transportation, and safety advantages to the user. Furthermore, thenovel configurations of the fluid pathway connections and drug pumps ofthe present invention maintain the sterility of the fluid path throughoperation of the device. Because the path that the drug fluid travelswithin the device is entirely maintained in a sterile condition, onlythese components need be sterilized during the manufacturing process.Such components include the drug container of the drive mechanism, thefluid pathway connection, the sterile fluid conduit, and the insertionmechanism. In at least one embodiment of the present invention, thepower and control system, the assembly platform, the control arm, theactivation mechanism, the housing, and other components of the drug pumpdo not need to be sterilized. This greatly improves themanufacturability of the device and reduces associated assembly costs.Accordingly, the devices of the present invention do not requireterminal sterilization upon completion of assembly. A further benefit ofthe present invention is that the components described herein aredesigned to be modular such that, for example, the fluid pathwayconnection and other components of the device may be integrated into ahousing and readily interface to function as a drug pump.

Assembly and/or manufacturing of fluid pathway connection 300, drugdelivery pump 10, or any of the individual components may utilize anumber of known materials and methodologies in the art. For example, anumber of known cleaning fluids such as isopropyl alcohol and hexane maybe used to clean the components and/or the devices. A number of knownadhesives or glues may similarly be employed in the manufacturingprocess. Additionally, known siliconization and/or lubrication fluidsand processes may be employed during the manufacture of the novelcomponents and devices. Furthermore, known sterilization processes maybe employed at one or more of the manufacturing or assembly stages toensure the sterility of the final product.

The fluid pathway connection may be assembled in a number ofmethodologies. In one method of assembly, the sterile fluid pathwayconnection may be assembled as shown in FIGS. 5A and 5B and thenattached, mounted, connected, or otherwise integrated into drugcontainer 50 such that at least a portion of the sliding pierceable seal56 is contained within the drug container 50. The drug container 50 maythen be filled with a fluid for delivery to the user and plugged with aplunger seal 60 at an end opposite the sliding pierceable seal 56. Thebarrel 58 may be filled with a drug fluid through the open proximal endprior to insertion of the plunger seal 60 from the proximal end of thebarrel 58. The drive mechanism 100 may then be attached to the proximalend of the drug container 50 such that a component of the drivemechanism 100 is capable of contacting the plunger seal 60. Theinsertion mechanism 200 may be assembled and attached to the other endof the fluid conduit 30. This entire sub-assembly, including drivemechanism 100, drug container 50, fluid pathway connection 300, fluidconduit 30, and insertion mechanism 200 may be sterilized, as describedabove, before assembly into the drug pump 10. Certain components of thissub-assembly may be mounted to an assembly platform within the housing12A, 12B or directly to the interior of the housing 12A, 12B, whileother components may be mounted to a guide, channel, or other componentor aspect for activation by the user.

Manufacturing of a drug pump includes the step of attaching both thefluid pathway connection and drug container, either separately or as acombined component, to an assembly platform or housing of the drug pump.The method of manufacturing further includes attachment of the drivemechanism, drug container, and insertion mechanism to the assemblyplatform or housing. The additional components of the drug pump, asdescribed above, including the power and control system, the activationmechanism, and the control arm may be attached, preformed, orpre-assembled to the assembly platform or housing. An adhesive patch andpatch liner may be attached to the housing surface of the drug pump thatcontacts the user during operation of the device.

A method of operating the drug pump includes one or more of thefollowing steps: activating, by a user, the activation mechanism;displacing a control arm to actuate an insertion mechanism; activating adrive control mechanism to push the plunger seal, connect the sterilefluid pathway connection, and drive fluid drug flow through the drugpump, wherein translating the fluid pathway connection causes a piercingmember to penetrate a pierceable seal thereby opening a fluid path froma drug container to the fluid pathway connection. The drive controlmechanism may be activated by actuating a power and control system. Themethod may further include the step of: engaging an optional on-bodysensor prior to activating the activation mechanism. Furthermore, themethod of operation may include translating a plunger seal within thedrive control mechanism and drug container to force fluid drug flowthrough the drug container, the fluid pathway connection, a sterilefluid conduit, and the insertion mechanism for delivery of the fluiddrug to the body of a user. The method of operation of the insertionmechanism and the drug pump may be better appreciated with reference toFIGS. 4A-4C, 6A-6D, and/or 7A-7D, as described above.

Throughout the specification, the aim has been to describe the preferredembodiments of the invention without limiting the invention to any oneembodiment or specific collection of features. Various changes andmodifications may be made to the embodiments described and illustratedwithout departing from the present invention. The disclosure of eachpatent and scientific document, computer program and algorithm referredto in this specification is incorporated by reference in its entirety.

What is claimed is:
 1. A fluid pathway connection comprises: a piercingmember, a connection hub, and a sliding pierceable seal, wherein thesliding pierceable seal is configured to move from a first position,where the piercing member is initially retained within a sterile cavitybetween the connection hub and the sliding pierceable seal, to a secondposition, where the pierceable seal has been penetrated by the piercingmember.
 2. The fluid pathway connection of claim 1, wherein the slidingpierceable seal is configured to move from the first position to thesecond position by a force applied by a drug fluid on the slidingpierceable seal.
 3. The fluid pathway connection of claim 1, whereinpenetration by the piercing member of the sliding pierceable seal uponmovement of the sliding pierceable seal from the first position to thesecond position opens a fluid pathway through the sliding pierceableseal and the piercing member to a fluid conduit.
 4. The fluid pathwayconnection of claim 1, wherein the pierceable seal has a seal barrierthat may be penetrated by the piercing member and the piercing member isinitially in contact with, or adjacent to, the seal barrier.
 5. Thefluid pathway connection of claim 1 further comprising a seal mountattached to the sliding pierceable seal, wherein the seal mount iscapable of engaging with and translating upon the connection hub andwherein the piercing member is initially in contact with, or adjacentto, the seal barrier.
 6. The fluid pathway connection of claim 1,wherein the piercing member passes into the connection hub and connectsto a fluid conduit.
 7. The fluid pathway connection of claim 1 furthercomprising one or more interconnects and, optionally, one or morecorresponding contacts to transmit a signal to the user.
 8. The fluidpathway connection of claim 7, wherein the interconnect is within or atleast partially proximal to a plunger seal translatable within a drugcontainer such that the piercing member is capable of penetrating theplunger seal and acting as a contact for the interconnect to transmit asignal to the user.
 9. The fluid pathway connection of claim 7, whereinone of either the interconnects and the contacts is within or at leastpartially proximal to a plunger seal translatable within a drugcontainer and the other is within or at least partially distal to thesliding pierceable seal to transmit a signal to the user when theplunger seal and the sliding pierceable seal are substantially incontact.
 10. The fluid pathway connection of claim 7, wherein theinterconnects and contacts are selected from the group consisting ofHall effect sensors; giant magneto resistance (GMR) or magnetic fieldsensors; optical sensors; capacitive or capacitance change sensors;ultrasonic sensors; and linear travel, LVDT, linear resistive, orradiometric linear resistive sensors; and combinations thereof, whichare capable of coordinating to transmit a signal to the user.
 11. Thefluid pathway connection of claim 1, further comprising one or more flowrestrictors.
 12. The fluid pathway connection of claim 1, furthercomprising a filter selected from the group consisting of permeablemembranes, semi-permeable membranes, and porous membranes, wherein thefilter encloses the sterile cavity from the outside environment.
 13. Anintegrated fluid pathway connection and drug container comprises: apiercing member, a connection hub, and a sliding pierceable sealintegrated at least partially within a drug container having a barreland a plunger seal, wherein the sliding pierceable seal is translatableupon a connection post of the connection hub and is configured to movefrom a first position, where the piercing member is initially retainedwithin a sterile cavity between the connection hub and the slidingpierceable seal, to a second position, where the pierceable seal hasbeen penetrated by the piercing member.
 14. The integrated fluid pathwayconnection of claim 13, wherein the drug container contains a drugchamber between the sliding pierceable seal and the plunger seal toinitially retain a drug fluid, and wherein the sliding pierceable sealis configured to move from the first position to the second position bya force applied by the drug fluid on the sliding pierceable seal. 15.The integrated fluid pathway connection of claim 13, wherein thepierceable seal has a seal barrier that may be penetrated by thepiercing member and the piercing member is initially in contact with, oradjacent to, the seal barrier.
 16. The integrated fluid pathwayconnection of claim 13 further comprising a seal mount attached to thesliding pierceable seal, wherein the seal mount slidably engages theconnection hub to permit translation of the sliding pierceable seal inthe distal direction but prevent translation in the proximal direction.17. The integrated fluid pathway connection of claim 13, wherein theconnection hub has a header with a conduit port, a chamber, and a vacuumport with a channel that leads into the chamber such that the sterilecavity may be evacuated through the channel.
 18. The integrated fluidpathway connection of claim 17, wherein the conduit port has a membraneto permit fluid flow out of the chamber and the vacuum port is capableof being plugged.
 19. The integrated fluid pathway connection of claim13, wherein the sliding pierceable seal is translatable upon theconnection post of the connection hub and is further configured to movefrom the second position, where the pierceable seal has been penetratedby the piercing member, to a third position where one or moreinterconnects and one or more corresponding contacts are permitted totransmit a signal to the user.
 20. The integrated fluid pathwayconnection of claim 19, wherein one of either the interconnects and thecontacts is upon an aspect of a drive mechanism and the other is withinor at least partially proximal to the plunger seal to transmit a signalto the user when the plunger seal and the sliding pierceable seal aresubstantially in contact.
 21. The integrated fluid pathway connection ofclaim 19, wherein one of either the interconnects and the contacts iswithin or at least partially distal to the pierceable sliding seal andthe other is proximal to the connection hub to transmit a signal to theuser when the plunger seal and the sliding pierceable seal aresubstantially in contact.
 22. The integrated fluid pathway connection ofclaim 19, wherein the interconnects and contacts are selected from thegroup consisting of Hall effect sensors; giant magneto resistance (GMR)or magnetic field sensors; optical sensors; capacitive or capacitancechange sensors; ultrasonic sensors; and linear travel, LVDT, linearresistive, or radiometric linear resistive sensors; and combinationsthereof, which are capable of coordinating to transmit a signal to theuser.
 23. The integrated fluid pathway connection of claim 13, furthercomprising a filter selected from the group consisting of permeablemembranes, semi-permeable membranes, and porous membranes, wherein thefilter encloses the sterile cavity from the outside environment.
 24. Adrug delivery pump with integrated sterility maintenance featurescomprises a housing within which an activation mechanism, an insertionmechanism, and a drug container having a plunger seal may be mounted,the drug container connected at one end to a drive mechanism and atanother end to a fluid pathway connection, said fluid pathway connectioncomprising a piercing member, a connection hub, and a sliding pierceableseal, wherein the sliding pierceable seal is configured to move from afirst position, where the piercing member is initially retained within asterile cavity between the connection hub and the sliding pierceableseal, to a second position, where the pierceable seal has beenpenetrated by the piercing member.
 25. The drug delivery pump of claim24, wherein the drug container contains a drug chamber between thesliding pierceable seal and the plunger seal to initially retain a drugfluid.
 26. The drug delivery pump of claim 24, wherein the pierceableseal has a seal barrier that may be penetrated by the piercing memberand the piercing member is initially in contact with, or adjacent to,the seal barrier.
 27. The drug delivery pump of claim 24 furthercomprising a seal mount attached to the sliding pierceable seal, whereinthe seal mount slidably engages the connection hub to permit translationof the sliding pierceable seal in the distal direction but preventtranslation in the proximal direction.
 28. The drug delivery pump ofclaim 24, wherein the connection hub has a header with a conduit port, achamber, and a vacuum port with a channel that leads into the chambersuch that the sterile cavity may be evacuated through the channel. 29.The drug delivery pump of claim 28, wherein the conduit port has amembrane to permit fluid flow out of the chamber and the vacuum port iscapable of being plugged.
 30. The drug delivery pump of claim 24,wherein the sliding pierceable seal is translatable upon the connectionpost of the connection hub and is further configured to move from thesecond position, where the pierceable seal has been penetrated by thepiercing member, to a third position where one or more interconnects andone or more corresponding contacts are permitted to transmit a signal tothe user.
 31. The drug delivery pump of claim 30, wherein the one ormore interconnects and the one or more corresponding contacts areconfigured such that either: (a.) one of either the interconnects andthe contacts is upon an aspect of the drive mechanism and the other iswithin or at least partially proximal to the plunger seal to transmit asignal to the user when the plunger seal and the sliding pierceable sealare substantially in contact; or (b.) one of either the interconnectsand the contacts is within or at least partially distal to thepierceable sliding seal and the other is proximal to the connection hubto transmit a signal to the user when the plunger seal and the slidingpierceable seal are substantially in contact.
 32. The drug delivery pumpof claim 30, wherein the interconnects and contacts are selected fromthe group consisting of Hall effect sensors; giant magneto resistance(GMR) or magnetic field sensors; optical sensors; capacitive orcapacitance change sensors; ultrasonic sensors; and linear travel, LVDT,linear resistive, or radiometric linear resistive sensors; andcombinations thereof, which are capable of coordinating to transmit asignal to the user.
 33. The drug delivery pump of claim 24 furthercomprising a filter selected from the group consisting of permeablemembranes, semi-permeable membranes, and porous membranes, wherein thefilter encloses the sterile cavity from the outside environment.
 34. Thedrug delivery pump of claim 24, wherein the piercing member passes intothe connection hub and connects to a fluid conduit.
 35. The drugdelivery pump of claim 24, wherein the connection hub connects thepiercing member to a fluid conduit, and wherein the fluid conduit is atleast partially a part of the connection hub.